By Counterforce Health Team in Evkeeza (evinacumab-dgnb) —

How to Get Evkeeza (Evinacumab) Covered by Blue Cross Blue Shield in Florida: Complete Coding, Appeals & Authorization Guide

Quick Answer: Getting Evkeeza Covered in Florida

Evkeeza (evinacumab-dgnb) requires prior authorization from Florida Blue Cross Blue Shield for homozygous familial hypercholesterolemia (HoFH). Your fastest path: 1) Confirm HoFH diagnosis with genetic testing and LDL-C ≥100 mg/dL, 2) Document failed trials of statins, ezetimibe, and PCSK9 inhibitors, 3) Submit prior authorization through Florida Blue's provider portal within 72 hours for standard review. If denied, you have 180 days to file an internal appeal and 4 months for external review through Florida's Department of Financial Services.

First step today: Contact Florida Blue at 1-800-477-3736 to verify your specific plan's formulary status and obtain the current prior authorization form.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Codes for HoFH Documentation
  3. HCPCS, J-Codes, and NDC Numbers
  4. Clean Prior Authorization Request
  5. Common Coding Pitfalls
  6. Florida Blue Verification Steps
  7. Pre-Submission Audit Checklist
  8. Appeals Process in Florida
  9. Cost Assistance Programs
  10. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Evkeeza falls under the medical benefit, not pharmacy benefit, because it's administered as an IV infusion in a healthcare setting. This distinction affects both billing and prior authorization pathways.

Coverage Requirements at a Glance

Requirement Details Documentation Needed
Prior Authorization Required for all plans PA form + clinical notes
Diagnosis HoFH confirmed ICD-10 E78.01
LDL-C Level ≥100 mg/dL (recent update) Lab results within 30 days
Failed Therapies Statins, ezetimibe, PCSK9i Treatment history
Administration IV infusion only Facility certification
Billing Code HCPCS J1305 5mg per unit

Source: Florida Blue Medical Policy Portal

ICD-10 Codes for HoFH Documentation

The primary diagnosis code is E78.01 (Familial hypercholesterolemia). For comprehensive documentation, you may also need:

  • Z83.42 - Family history of familial hypercholesterolemia
  • Z87.891 - Personal history of nicotine dependence (if applicable)
  • Z51.12 - Encounter for antineoplastic chemotherapy (if concurrent)

Documentation Requirements

Your medical records must clearly establish:

  1. Genetic confirmation: Document results showing two pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  2. Clinical criteria: If genetic testing unavailable, document clinical diagnosis based on LDL-C levels >400 mg/dL and family history
  3. Physical findings: Note xanthomas, corneal arcus, or premature cardiovascular disease
  4. Treatment resistance: Record inadequate response to maximum tolerated conventional therapies
Tip: Use specific language like "homozygous familial hypercholesterolemia confirmed by genetic testing" rather than general terms like "high cholesterol."

HCPCS, J-Codes, and NDC Numbers

Billing Code: J1305

  • HCPCS Code: J1305 (Injection, evinacumab-dgnb, 5 mg)
  • Billing Units: Each unit = 5 mg
  • Typical Adult Dose: 15 mg/kg monthly (345 units for 115 kg patient)

NDC Numbers

  • 345 mg/2.3 mL vial: 61755-0013-xx
  • 1,200 mg/8 mL vial: 61755-0010-xx

Revenue Codes for Hospital Billing

  • 0636: Drugs requiring detailed coding
  • 0260: IV therapy
  • 0250: Drugs and biologicals

Medicare Modifiers (if applicable)

  • JW: Drug amount discarded
  • JZ: Zero drug amount discarded

Source: UnitedHealthcare Provider Policy

Clean Prior Authorization Request

Required Elements for Florida Blue PA

Patient Information:

  • Full name, DOB, member ID
  • Primary care physician and referring specialist
  • Diagnosis: HoFH with ICD-10 E78.01

Clinical Documentation:

  • Genetic test results confirming homozygous status
  • Recent lipid panel (LDL-C ≥100 mg/dL)
  • Complete medication history with dates, doses, and outcomes
  • Documentation of contraindications or intolerances to standard therapies

Prescriber Information:

  • DEA number and NPI
  • Specialty certification (endocrinology, cardiology, or lipidology preferred)
  • Contact information for peer-to-peer review

Treatment Plan:

  • Dosing: 15 mg/kg IV every 4 weeks
  • Administration site: Certified infusion center
  • Monitoring plan: Lipid panels every 3 months initially
Note: Florida Blue typically responds within 72 hours for standard requests and 24 hours for expedited reviews.

Common Coding Pitfalls

Unit Calculation Errors

Problem: Billing wrong number of J1305 units Solution: Always divide total mg by 5. For 1,725 mg dose = 345 units (1,725 ÷ 5)

Diagnosis Code Mismatches

Problem: Using E78.5 (unspecified hyperlipidemia) instead of E78.01 Solution: Ensure genetic testing or clinical criteria clearly support familial hypercholesterolemia diagnosis

Missing Modifiers

Problem: Not reporting drug waste with JW modifier Solution: Calculate and report any discarded medication amounts for Medicare patients

Wrong Benefit Category

Problem: Submitting under pharmacy benefit Solution: Always bill as medical benefit using HCPCS J1305, not NDC

Florida Blue Verification Steps

Before Submitting Your Request

  1. Check Formulary Status: Log into Florida Blue provider portal or call 1-800-477-3736
  2. Verify PA Requirements: Confirm current prior authorization form and submission method
  3. Review Medical Policy: Check for recent updates to coverage criteria
  4. Confirm Network Status: Ensure infusion facility is in-network

Submission Channels

  • Provider Portal: FloridaBlue.com/providers
  • Fax: Verify current fax number with customer service
  • Phone: 1-800-477-3736 for urgent requests

Source: Florida Blue Provider Forms

Pre-Submission Audit Checklist

Clinical Documentation:

  • HoFH diagnosis confirmed with E78.01 code
  • Genetic testing results included
  • Recent LDL-C level ≥100 mg/dL documented
  • Complete prior therapy history with outcomes
  • Contraindications to standard therapies noted

Billing Information:

  • Correct HCPCS code J1305
  • Accurate unit calculation (mg ÷ 5)
  • Proper NDC number for vial size
  • Appropriate revenue codes for facility

Administrative Details:

  • Complete patient demographics
  • Valid insurance information
  • Prescriber NPI and DEA numbers
  • Infusion site certification verified

Appeals Process in Florida

Internal Appeal (First Level)

Timeline: 180 days from denial notice Process: Submit written appeal with additional clinical evidence Decision: 30 days for non-urgent, 72 hours for urgent

External Review (State Level)

Timeline: 4 months after final internal denial Process: Contact Florida Department of Financial Services at 1-877-693-5236 Cost: Free to consumers Decision: Binding on Florida Blue if approved

Required Documents for Appeals

  • Original denial letter
  • Complete medical records
  • Peer-reviewed studies supporting Evkeeza use
  • Physician attestation letter
  • Failed therapy documentation
From our advocates: "We've seen the strongest appeals include genetic testing results, detailed treatment timelines, and citations to FDA labeling. One case involved a 28-year-old with documented statin intolerance—the external reviewer overturned the denial after reviewing comprehensive genetic and clinical evidence."

Cost Assistance Programs

Manufacturer Support

Regeneron MYEVKEEZA: Copay assistance up to $12,000 per year for eligible commercially insured patients Enrollment: Visit MYEVKEEZA.com or call 1-833-EVKEEZA

Foundation Programs

  • Patient Access Network (PAN): Rare disease fund
  • Good Days: Chronic disease assistance
  • HealthWell Foundation: Cardiovascular grants

State Resources

Florida Medicaid: May cover if eligible and medically necessary Contact: 1-877-711-3662

Source: Evkeeza HCP Website

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Evkeeza. Their platform analyzes denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements, helping patients and providers navigate the complex prior authorization landscape more effectively.

FAQ

Q: How long does Florida Blue prior authorization take? A: Standard reviews take up to 72 hours; expedited reviews for urgent cases take 24 hours.

Q: What if Evkeeza isn't on my formulary? A: You can request a formulary exception with medical necessity justification and evidence that alternatives are inappropriate.

Q: Can I appeal if I live in Florida but have a national Blue plan? A: Yes, but appeal procedures may differ. Check your specific plan documents for appeal rights and timelines.

Q: What LDL-C level qualifies for Evkeeza coverage? A: Recent policy updates require LDL-C ≥100 mg/dL despite maximum tolerated therapy, up from the previous 70 mg/dL threshold.

Q: Do I need genetic testing to get approved? A: While not always required, genetic confirmation of HoFH significantly strengthens your prior authorization request.

Q: What happens if my appeal is denied? A: You can request external review through Florida's Department of Financial Services, which provides independent medical review at no cost.

Q: Can I start treatment before approval? A: Not recommended. Evkeeza costs approximately $450,000 annually, and insurers won't cover retroactive costs for unapproved treatments.

Sources & Further Reading

For additional support navigating the prior authorization process, Counterforce Health provides specialized assistance in crafting evidence-based appeals for complex specialty medications.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with your specific Florida Blue plan and consult healthcare professionals for medical decisions. For official appeals assistance, contact Florida's Department of Financial Services at 1-877-693-5236.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.